Veru Inc. · NASDAQ:VERU
Veru — Female Health — Merger or Acquisition (April 2016)
42 slides from Veru's merger presentation, Apr 12, 2016
Slide 1: Proposed Merger of Aspen Park Pharmaceuticals and The Female Health Company
Proposed Merger of Aspen Park Pharmaceuticals and The Female Health Company Transforming into A Leading Men’s and Women’s Health Care Company April 2016 NASDAQ: FHCO Exhibit 99.1
Slide 2: Forward Looking Statements
This communication contains forward-looking statements, including those regarding the proposed merger transaction between FHC and APP and the integration of our two businesses. These statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertaint
Slide 3: Additional Information about the Proposed Transaction and Where You Can Find It
Additional Information about the Proposed Transaction and Where You Can Find It FHC plans to file a proxy statement with the SEC relating to a solicitation of proxies from its shareholders in connection with a special meeting of shareholders of FHC to be held for the purpose of voting on matters rel
Slide 4: The Proposed Merger of Aspen Park Pharmaceuticals (APP) and The Female Health Company (FHC)
Merged company New name will be selected to reflect new business Reincorporate FHC as a Delaware corporation Global headquarters, Miami, Florida Women’s Health Division Office, Chicago FC2 compliance and international activities, London FC2 manufacturing, Malaysia Ownership will be approximately 45%
Slide 5: APP – FHC Merger Co. Addressing Large Global Markets
Men Prostate cancer, including side effects of treatments, >$6.4 billion1 Benign prostatic hyperplasia (BPH) >$5.2 billion2 Sexual dysfunction >$4 billion3 Premature ejaculation >$500 million4 Male infertility >$700 million5 Gout >$1.5 billion6 Women Breast cancer >$3 billion7 Ovarian cancer >$1.5 b
Slide 6: Combined portfolio establishes leader in men's and women's health care
Combined portfolio of products and expertise establishes the new company as a leader in men’s and women’s health care Complementary diversification strategy with multiple shots on goal Deep value, opportunistic, late stage development and near term products for large markets Portfolio mostly less ri
Slide 7: Experienced Management Team for APP-FHC Merger Co.
Mitchell Steiner, MD – CEO and President. Urologist, Aspen Park Pharmaceuticals, OPKO Health, Inc. and GTx, Inc. Harry Fisch, MD – Chief Corporate Officer. Urologist, Aspen Park Pharmaceuticals and Millennium Sciences, Inc. Daniel Haines, CPA - Chief Financial Officer. E&Y, Equity One, Inc. (NYSE:EQ
Slide 8: Board of Directors
Elgar Peerschke, MBA – Chairman. President of Quintiles; Senior partner Global Health Care Practice of Bain and Company Mitchell Steiner, MD – Vice Chairman and CEO and President of the Company. Cofounder, CEO, President of Aspen Park Pharmaceuticals; President urology OPKO Health (NYSE:OPK); Cofoun
Slide 9: Board of Directors (continued)
Georges Makhoul - Director. CEO of Constellation Holdings; President Morgan Stanley Investment Banking Europe, Middle East, and North Africa; and led National Science Foundation Research Center at Columbia University Mario Eisenberger, MD - Director. Professor of Oncology Johns Hopkins University; h
Slide 10: A Men's and Women's Health Care Company
3_85 APP-FHC Merger Co. A Men’s and Women’s Health Care Company Focused on Pharmaceutical and Consumer Health Products APP – FHC Merger Co. Women’s Health Men’s Health Tamsulosin DRS- BPH MSS-722- Male infertility APP-944- Hot flashes prostate cancer APP-111- Prostate cancer APP-111/112- Gout and FM
Slide 11: Men's Health Division Pharmaceuticals and Products Candidates in Development
Men’s Health Division Pharmaceuticals and Products Candidates in Development Benign prostate hyperplasia Tamsulosin Delayed Release Sachet (DRS) 505(b)(2) FDA pathway Bioequivalence study planned Q4 2016 and file NDA 2017 U.S. patent on proprietary formulation applied for in 2015 Male infertility MS
Slide 12: Benign Prostate Hyperplasia, Well-Established Market
Alpha blocker benign prostatic hyperplasia (BPH) therapeutics class generated $4.1 billion in U.S. pharmacy sales1 (in 2014) 12% is associated with long-term care facilities1 Tamsulosin (FLOMAX®) is currently the number one prescribed alpha blocker treating the Medicare (long-term care) population1
Slide 13: BPH Alpha Blocker Sales: Tamsulosin Has ~85% Market Share
BPH Alpha Blocker Sales Tamsulosin (FLOMAX®) Has ~85% Market Share ATC4 MAT Mar 2015 TRx MAT Mar 2015 TRx Market Share MAT Mar 2015 TRx Pharmacy $ MAT Mar 2015 TRx Pharmacy $ Market Share MAT Mar 2015 EUTRx $/Unit G04C2 BPH A-ADRENERG ANTAG PLN 29,233,610 100.00% $4,142,576,343 100.00% 1,478,295,890
Slide 14: Tamsulosin DRS No Sales Force Needed
Initiate a focused contracting strategy (rebate/performance based) with specialty GPOs to provide immediate access to long term care population 12% of market in long term care facilities 2 Labs, Inc. has expertise in contracting with all third party logistics and providers Tamsulosin DRS can be diff
Slide 15: Tamsulosin DRS Anticipated Clinical Development Plan
Drug API/ Product Tamsulosin DRS Anticipated Clinical Development Plan 505(b)(2) Indication: BPH 2015 2016 2017 BE study 140294_84 3_84 4_84 48_84 65_84 70_84 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q PreIND Meeting 505(b)(2) File NDA 2018 2Q 1Q 3Q 4Q PreNDA Meeting 505(b)(2) Launch
Slide 16: Male Infertility A Growing and Underserved Market
Male Infertility A Growing and Underserved Market Infertility affects 6.1 million couples in US, which is 15% of all couples trying to conceive1 50% of infertility is attributed to males who present with abnormal semen analysis1,2 2% of infertile men have adult onset form of idiopathic hypogonadotro
Slide 17: MSS-722 Male Infertility Efficacy Data from Literature
18_85 11_84 MSS-722 Male Infertility Efficacy Data from Literature Efficacy Chua M et al Andrology 1:749-757 2013.
Slide 18: MSS-722 Clomiphene Safety in Men & Women
18_85 11_84 MSS-722 Clomiphene Safety in Men & Women Carmargo Pharmaceutical Services Feasibility and Clinical Report 3/3/15 39 published studies in men taking clomiphene 2220 men, duration from 8 weeks to 3 years, and doses from 25mg-200mg/day Reported adverse events included visual symptoms (blurr
Slide 19: MSS-722 Treatment of Male Infertility - FDA Meeting May 28th 2015
FDA confirmed that MSS-722 qualifies for 505(b)(2) pathway Utilize a fixed proprietary ratio of cis and trans isomers Indication of idiopathic male infertility with hypogonadotropic hypogonadism not due to primary testicular failure would be acceptable* Population - men with hypogonadotropic hypogon
Slide 20: MSS-722 Clinical Development Plan
Drug API/ Product MSS-722 Clinical Development Plan 505(b)(2) Indication: Infertility in Men with Hypogonadism 2015 2016 2017 Phase 2 Dose finding Interim analysis 2.5 months Final 5 months 120 patients 140294_84 3_84 4_84 48_84 65_84 70_84 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q Phase 3 X 2 8 months Pr
Slide 21: APP-944 Oral Drug for Hot Flashes in Men on Prostate Cancer Therapy
18_85 11_84 APP-944 Oral Drug Product for the Treatment of Hot Flashes in Men on Prostate Cancer Hormonal Therapy Hot flashes are the most common and distressing side effect of androgen deprivation therapy and other hormone therapies for prostate cancer Up to 80% of men treated with hormone therapie
Slide 22: APP-111 Oral Novel Tubulin Targeting Chemotherapy for Advanced Prostate Cancer
APP-111 Oral Novel Tubulin Targeting Chemotherapy for Advanced Prostate Cancer 4_81 $5 billion market for secondary hormone therapies for prostate cancer1 and $4.8B market for taxanes & vinca alkaloids (Docetaxel $1B & cabazitaxel $500 million in prostate cancer)2 Emerging Indications: Secondary hor
Slide 23: APP-111 Oral Novel Tubulin Targeting Chemotherapy
APP-111 Oral Novel Tubulin Targeting Chemotherapy 4_81 Proof-of-concept preclinical studies were successful. We have a drug!! Low nanomolar tubulin inhibition Binds to colchicine site of tubulin High oral bioavailability High brain penetration Not substrate MDRs (P-gp, MRPs, and BCRP) Not substrate
Slide 24: APP-111 Anticipated Clinical Development Plan
APP-111 Anticipated Clinical Development Plan Indication: Enzalutamide Resistant Prostate Cancer 2015 2016 2017 140294_84 3_84 4_84 48_84 65_84 70_84 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2018 2Q 1Q 3Q 4Q Drug API/ Product Open label Phase1a Phase 2 PreIND Meeting File IND Safety Pharm & Acute Tox 28d
Slide 25: APP-111 Potential Platform Technology
APP-111- Potential Platform Technology IV Anti-tubulins Have Demonstrated Activity Against a Broad Group of Tumor Types Vinca Alkaloids – primarily used in combination chemotherapy (ABVD, Stanford-V, CHOP, MOPP) for hematologic malignancies (leukemia, lymphoma, myeloma, sarcoma), and some neuroblast
Slide 26: Gout is the Most Common Form of Inflammatory Arthritis in Men Over 40
Gout is a type of arthritis characterized by sudden, severe attacks of joint pain because of the deposition of uric acid crystals in the joints Gout is 10x more common in men than women In the US, 8.3 million people with gout and the incidence is increasing Global market for gout drugs exceeds $1.5
Slide 27: Current Gout Therapy Effective, But...
Colchicine is effective to treat and to prevent acute attacks, but has side effects such as abdominal cramping, nausea, and diarrhea Low therapeutic index (low safety margin) Drug-drug interactions are common APP-111/112 is an oral, novel small molecule that binds to same drug target site as colchic
Slide 28: Men's Health Division Consumer Health Products
Men’s Health Division Consumer Health Products Reducing the incidence of premature ejaculation PREBOOST® OTC product Desensitizing individual wipes FDA approved (compliant with FDA OTC monograph) Phase 4 to be completed in 2016 Market launch Q3 2016 Sexual health vitamin supplement Special formulati
Slide 29: PREBOOST Reducing the Incidence of Premature Ejaculation
18_85 11_84 PREBOOST™ Reducing the Incidence of Premature Ejaculation Compliant with FDA OTC monograph Only individual medicated wipes containing benzocaine that temporarily desensitizes penis after topical application Helps in temporarily prolonging time to ejaculation Each box contains 10 individu
Slide 30: Men's Health Division Program Milestones and Costs
Men’s Health Division 2016 2017 140294_84 3_84 4_84 48_84 65_84 70_84 2018 Products APP-111 advanced prostate cancer** Phase 1a Phase 2 Tamsulosin DRS For BPH* Phase 1b BE study NDA Launch MSS-722 for male infertility NDA Phase 2 Phase 3 APP-944 for hot flashes Phase 2 Phase 3 APP-111/112 acute gout
Slide 31: Female Health Company: FC2 Female Condom
Growing single consumer health product- FC2 Female Condom Sold in US and 144 countries Over 500 million units sold to date, 62 million units sold in 2015 Manufacturing capacity at 100 million units, can add another 100 million units in capacity Almost all public sector customers, expanding into priv
Slide 32: Women's Health Division Pharmaceutical Products Candidates and Consumer Health Products
Women’s Health Division Pharmaceutical Products Candidates and Consumer Health Products Continue the Passion and Dedication to Grow Division Anti-tubulin cytotoxic therapy APP-111, oral tubulin targeting chemotherapy drug product candidate New chemical entity Preclinical toxicology study 2016 Phase
Slide 33: FC2 Female Condom: Demand Should Continue to Grow Globally
18_85 11_84 FC2 Female Condom: Demand Should Continue to Grow Globally Continued Global Focus on HIV AIDS – leading cause of death women age 15-44 35 million persons living with AIDS, 2.3 million newly infected in 2012 Increasing incidence of STIs around the world 20 million new cases every year in
Slide 34: FC2 Female Condom: Demand Should Continue to Grow in United States
18_85 11_84 FC2 Female Condom: Demand Should Continue to Grow in United States Medical approach Non-hormonal birth control alternative Many US women report dissatisfaction with the side effects of hormonal birth control- diaphragm has been discontinued Reimbursed with prescription by Affordable Care
Slide 35: Anticipated Milestones
Anticipated Milestones Flow of Clinical & Regulatory News Creates Opportunities to Influence Shareholder Value 1471515_85 1471517_85 1471518_85 21_85 Product 2016 2017 2018 PREBOOST Launch FC2 Expand into US and European private markets MSS-722 Initiate Phase 2 fertility data Get orphan drug status
Slide 36: Men's Health Product Portfolio
3_85 Men’s Health Division Men’s Health Product Portfolio Product Indication Key Differentiation Expected NDA filing Current US Market Size PREBOOST Premature Ejaculation OTC convenient individual medicated wipes FDA preapproved OTC $500 million Tamsulosin DRS Benign Prostatic Hyperplasia Delayed re
Slide 37: Women's Health Product Portfolio
3_85 Women’s Health Division Women’s Health Product Portfolio Product Indication Key Differentiation Expected NDA filing Current US Market Size FC2 Prevention of sexually transmitted HIV and pregnancy Only FDA approved female condom FDA approved US female condom market in early stages. US male condo
Slide 38: Selected Unaudited Combined Financial Highlights
As of and for the Year Ended September 30, 2015 (in millions) As of and for the Three Months Ended December 31, 2015 (in millions) Net Revenues $32.6 $8.2 Operating Income 5.4 2.1 Net Income $3.1 $1.3 Cash & Accounts Receivable $18.8 $21.8 Selected Unaudited Combined Financial Highlights Note: FHC a
Slide 39: Why Vote For the Merger?
Seasoned management team with over 30 years average experience in the medical industry FHC brings a financially strong company with a successful track record, while APP brings a multi-product portfolio with significant upside potential Combined company will have successful existing products, togethe
Slide 40: Thank You
| ASPEN|PARK = @ THANK YOU
Slide 41: Appendix
| ASPEN|PARK = @ APPENDIX
Slide 42: APP-111 Potential First-in-class Oral Anti-tubulin Drug Targeting Colchicine Binding Site
3_85 APP-111 Potential to be First-in-class Oral Anti-tubulin Drug to Target the Colchicine Binding Site Chen J et al J. Med Chem 55:7285-7289, 2012 APP-111 This binding pocket is located on the interface between α and β-subunit of tubulin dimer and extended inside to the nucleoside-binding domain t